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The Plague of Causation in the National Childhood Vaccine Injury Act

The last twenty years has seen a sea-change in the area of proving causation in the toxic tort setting, with courts demanding stronger, scientifically-tested evidence. At the same time, a closely related debate has been raging about separating cause from coincidence for injuries that might have been the result of vaccinations under the National Childhood Vaccine Injury Act compensation program. The Vaccine Act created a no-fault compensation fund financed by a tax on childhood vaccines to address harms resulting from those vaccines. Unfortunately, Congress gave little direction with regard to the level of certainty on causation that would be required under the program in the initial legislation, assuming that better science would be developed on vaccine causation. The Department of Health & Human Services, intimately involved in the program, takes the position that causal proof must be backed by “hard science” under the program. The Federal Circuit, the federal court charged with overseeing the program, has gradually been relaxing the sufficiency standard for causal proof. This article argues that the Federal Circuit, while implementing a program with different policy goals and not constrained by toxic tort law, has gone too far under the Act as written, but that the logic of their decisions should cause Congress to amend the Act.

Resolving the appropriate level of proof of causation is critically important. Requiring too high a standard would leave worthy victims uncompensated and potentially threaten vaccine supplies as manufacturers, concerned about liability exposure, withdraw from the market. But too low a standard could open the floodgates to unworthy claims and suggest to the public that vaccines present risks that outweigh their benefits, damaging their integrity.